YY/T 0891-2013Particular specifications for angiographic injector (English PDF)

3.1 Angiographic injector

The injector used to rapidly inject a sufficient amount of contrast agent to the inspection site in a certain period of time, in the diagnosis or treatment of vascular intervention angiography, in order to obtain the required medical image with the use of X-ray angiography equipment.

3.2 Injector head

The part equipped with injection push mechanism and supporting syringe.

3.3 Flow rate

The dosage of the contrast agent injected per unit of time, in milliliters per second (mL/s).

3.4 Rise time

The time taken from the start of the injection to when it reaches the set flow rate, in seconds.

3.5 Maximum injection pressure

The maximum pressure that can be reached at the time of injection of an injector.

5.1 Working conditions

5.1.1 Environmental conditions

Unless otherwise specified, the working conditions of the injector shall meet.

5.1.2 Power supply conditions

The power supply conditions of the injector shall meet.

5.2 Flow rate

The flow rate range of injectors for hearts and large vessels shall not be less than 1.0 mL/s to 30 mL/s. When the flow rate is less than or equal to 15 mL/s, the deviation shall not be greater than ±5 %; when the flow rate is greater than 15 mL/s, the deviation shall not be greater than ±10 %.

5.4 Fill rate

The fill rate of injectors shall be specified in the product standard, the deviation shall not be greater than ±5 %.

5.5 Maximum injection pressure

The maximum injection pressure of injectors for hearts and large vessels shall not be less than 6.89 MPa (1000 psi).

5.6 Pressure limit

The device shall be capable of setting the pressure limit during injection. When the pressure limit is less than or equal to 4.13 MPa (600 psi), the deviation shall not exceed ±0.34 MPa (50 psi); when the pressure limit is greater than 4.13 MPa (600 psi), the deviation shall not exceed ±0.48 MPa (70 psi).

5.9 Rise time

The setting range of the rise time should be specified in the product standard.

5.10 Rotation angle of injector head

The angle between the upward injector head and the horizontal plane shall not be less than 60°, and the angle between the downward injector head and the horizontal plane shall not be less than 10°.

5.11 Functions

The injector shall have the following functions.

5.12 Appearance

It shall meet the following requirements. […]

5.14 Security

It shall meet the requirements of GB 9706.1-2007 and GB 9706.15-2008.

6.1 Working conditions

6.1.1 Environmental conditions

It shall comply with the specifications of 5.1.1.

6.1.2 Power supply conditions

The power supply conditions are as follows. […]

6.2 Flow rate

The test medium is distilled or deionized water. The injection dose is set to 100 mL, and the flow rate is set to the minimum value and 50 % of the maximum value respectively.

6.3 Injection dose

The test medium is distilled or deionized water. SET the injection dose to 2 mL (when the flow rate is the minimum value), 20 mL (when the flow rate is 50 % of the maximum value) and 40 mL (when the flow rate is the maximum value); USE a balance to weigh the distilled water and convert it to capacity; CALCULATE the injection dose deviation, which shall meet the requirements of 5.3.

6.4 Fill rate

The test medium is distilled or deionized water. USE a timer to count the time taken from the start to the end of the filling signal; DETERMINE the capacity of the filled injection agent by weighing the weight of the container before and after filling;

CALCULATE the fill rate, which shall meet the requirements of 5.4.

6.7 Injection delay

SET the delay time to 3 s; USE a timer to count the time taken from receiving the signal to starting the injection; CALCULATE the injection delay deviation, which shall meet the requirements of 5.7.

6.9 Rise time

Actual operation, which shall meet the requirements of 5.9.

6.10 Rotation angle of injector head

Actual operation, measured with a goniometer. […]